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Electronic Data Capture (EDC)

Our project teams specialize in setting up eCRF applications and in managing external high-quality EDC data.

Biotrial has chosen to work with Medidata Rave and Clincase, both proficient eCRFs (electronic case report form) which can be adapted to study requirements. These user-friendly tools can integrate Custom Reporting, Pharmacovigilance reporting, Randomization and Drug Supply, Risk Based and Targeted Monitoring tools.

Biotrial’s EDC team has the expertise to evaluate a wide variety of EDC systems and is available to advise sponsors on the best solution.

Tools

Typing On Laptop Close Up. Man Working On Computer

Rave is the EDC industry leader and as such Biotrial has begun to implement this on clinical trials starting in 2015. Rave has been set up and managed by our Data Management group on numerous types of trials since then.

This collaboration allows sponsors to access the industry leading software in the hands of Biotrial’s expert team.

With extensive Biometrics experience in all Clinical Phases, we have been working with Clincase® since 2009. Sponsors appreciate Clincase® for its ergonomic design and positive site user feedback. Clincase is a cost effective and regulatory compliant (21CFR Part 11) software.

Randomization

Biotrial manages local and central randomization for clinical trials. Central Randomization services are managed within the Biostatistics group and use adapted software solutions, integrated to a trial’s EDC platform.

Biotrial’s Biostatistics team includes Randomization managers who oversee central randomization throughout a protocol and statisticians who assist with randomization list editing and definition of randomization schemes.

e-PRO

Assisting sponsors in the deployment of patient-centric solutions or simply providing user-friendly tools for clinical site staff to collect certain endpoints are crucial elements of Biotrial’s service.

Our group uses either full-service or BYOD (bring your own device) approaches to bring the best-adapted solution to a clinical trial whether this is to simply capture a patient diary or monitor compliance, or if we need to capture a complex clinical score.

team

Study Builder

Expert in programming EDC including Randomization, Reporting and Validation programs.

DM Project Leader

Has global oversight of all EDC-related elements of the trial.

Services Solution Manager

In charge of feasibility and implementation of trial-specific developments.

Randomization Manager

Independent team member with oversight of randomization activities.

Related Information

Medical Writing Biostatistics Pharmacokinetics Data Management Preclinical Clinical Core Lab Bioanalysis